Analytical development

Pharmaterials provides analytical development services as part of our FIRST IN MAN FAST service.

Our analytical chemists develop and validate analytical methods for your new pharmaceutical product, monitor its ongoing stability, and support the formulation development and clinical manufacturing.

Alongside our hplc analytical work we have a vast array of complementary techniques ranging from different sepctroscopies and a full capability to analyse physical forms with powder X-ray diffraction, differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), gravimetric vapour sorption (GVS) and others.  As providers of fully comprehensive chemical and physical analysis we are able to provide you with as much understanding of your API as you desire and to produce formulations that are of the quality you desire for the stage of development that you have reached.

Analytical development services include:

• Method development and validation
• Full physico-chemical profiling as required
• Cleaning method development and validation
• Dissolution and drug release profiling
• Forced degradation studies
• Stability monitoring to ICH guidelines
• Understanding of the causes of any batch-to-batch variability

Please contact us for further details.